Testing laboratories seeking ISO/IEC 17025 accreditation will be affected in various aspects.
The difference between formal ISO 17025 accreditation and good analytical practices is the amount of necessary documentation.
Generally, good analytical laboratories validate methods, check the performance of testing equipment, and use qualified analysts.
Unfortunately, they sometimes forget to wholly document test results.
This shows the importance of documentation because ISO/IEC 17025 accreditation requires a formal documented environment.
Samples and Test Data Workflow
A typical laboratory workflow of samples and test data workflow shows the complete impact of ISO 17025 accreditation on a testing laboratory.
- Sampling plan and sampling documentation.
- Sampling identification and protection of sample integrity.
- Monitoring the quality of test results.
- Test conditions and test results with estimated uncertainty.
- Ensure record integrity and security.
Analytical Workflow Requirements
Note that the organizational structure should ensure no conflicting interests could affect quality.
Hence, regular internal audits must assess compliance with ISO/IEC 17025 and internal procedures.
A laboratory must validate all analytical methods and procedures for sampling, testing, and data evaluation. It must also calibrate, test, and maintain equipment used for sampling and testing.
Calibration standards should be qualified and traceable to the System International (SI) units or certified reference material.
Furthermore, a laboratory should document and control non-conforming test results. It should also develop and maintain particular documents such as a quality plan and individual policies.
On the other hand, routine tasks must be executed according to written procedures. Therefore, employees assigned for tasks should be qualified based on education, training, and experience.
Besides, a laboratory must formally follow up all complaints from customers. Consequently, it should correct all existing problems. It also needs to develop an action plan to prevent the repetition of similar problems.
Moreover, it must monitor and control environmental situations like humidity and temperature.
Finally, a laboratory should use a formal program to handle subcontractors, service providers, and suppliers.
Compliance Across All Workflow Steps
- Authentication of analytical methods and procedures
- Equipment calibration testing and maintenance
- Qualification of material
- Control of non-conforming testing
- Qualification of employees
- Controlled environmental situations
- Written procedures
Compliance Across the Laboratory
- Documentation control
- Corrective and preventive actions
- Complaint handling
- Supplier, service provider, and subcontractor management
- Non-conflicting organizational structure
- Internal audits
8 Steps Towards ISO 17025 Accreditation for Laboratories
First, the management must identify a project owner. Afterward, the project owner studies information about the standard, reviews supporting literature, and examines other important data.
Next, the project owner defines the accreditation’s preliminary scope. He or she must work with laboratory professionals to develop a list of requirements.
Then, the project owner and laboratory professionals should conduct a gap analysis to establish the difference between the requirements and what is currently implemented in the laboratory.
After that, the project owner, laboratory professionals, documentation professionals, financing professionals, and external consultants will estimate the costs for accreditation using the results of the gap analysis.
Subsequently, the projected cost and incremental opportunities will be presented to the management.
When the management agrees to carry on with the accreditation, only then can the project owner lead the implementation phases.
The implementation phases require a volume of documentation. This can also impact your laboratory’s daily workflow.
QSE Academy aims to promote global recognition without disrupting your laboratory’s processes.